UMIN-CTR Clinical Trial

Basic information
Public title	The prospective study of halitosis improvement by eradicating Helicobacter pylori.
Acronym	The prospective study of halitosis improvement by eradicating Helicobacter pylori.
Scientific Title	The prospective study of halitosis improvement by eradicating Helicobacter pylori.
Scientific Title:Acronym	The prospective study of halitosis improvement by eradicating Helicobacter pylori.
Region	Japan

Condition
Condition	Gstric infection of Helicobacter pylori
Classification by specialty	Gastroenterology Dental medicine Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluated the halitosis improvement by eradicating Helicobacter pylori
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Halitosis value
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration	Institution is not considered as adjustment factor.
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Eradication of Helicobacter pylori
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients of both sexes were selected among those who met all criteria below. 1-1. Patients undergoing upper endoscopy at the clinic 1-2. H. pylori-positive patients without a history of eradication 1-3. Patients who were explained about the rights and responsibilities associated with participation in this study and who provided written consent 1-4. Patients aged 20 years and older at the time of obtaining the informed consent
Key exclusion criteria	2-1. Cases who had presented allergies to drugs contained in the eradication agent 2-2. Patients with a history of upper gastrointestinal tract surgery and pancreatoduodenectomy 2-3. Patients with malignancy detected by upper endoscopy or another test 2-4. Patients requiring upper emergency endoscopy 2-5. Patients with serious underlying disease (respiratory, cardiovascular, or endocrine disease) 2-6. Patients undergoing dialysis 2-7. Patients who were deemed ineligible for this trial by the principal investigator or co-investigators
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yui Kudo
Organization	Kudo clinic
Division name	Kudo clinic
Zip code
Address	Nakadori 1-3-5 Akita city Japan
TEL	018-825-9100
Email	info@kudo-clinic.com

Public contact
Name of contact person	1st name Middle name Last name Yui Kudo
Organization	Kudo clinic
Division name	Kudo clinic
Zip code
Address	Nakadori 1-3-5 Akita city Japan
TEL	018-825-9100
Homepage URL
Email	info@kudo-clinic.com

Sponsor
Institute	Kudo clinic
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2015 Year 02 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2015 Year 02 Month 02 Day
Date of IRB	2017 Year 08 Month 11 Day
Anticipated trial start date	2015 Year 02 Month 02 Day
Last follow-up date	2018 Year 10 Month 30 Day
Date of closure to data entry	2022 Year 02 Month 01 Day
Date trial data considered complete	2022 Year 02 Month 28 Day
Date analysis concluded	2022 Year 02 Month 28 Day

Other
Other related information

Management information
Registered date	2015 Year 01 Month 29 Day
Last modified on	2022 Year 03 Month 24 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000019018